Related Links:
Phase II Studies Explained Page
Introduction
Sample Size Tables
Javascript Program
References
Introduction
Technical Considerations
Example
This page provides explanations, sample size tables, and calculations for Phase II trials, where
the sample size needed is determined by Simon's procedure.
Only Simon's two stage procedure will be discussed in this page. Readers are referred to the Phase II Studies Explained Page
for Phase II studies generally and for comparison with other procedures available.
Simon's is a two stage procedure.
- The first stage requires a small sample size (n1), and sets a bench mark number of successes (r1) above which the
trial enters the second stage. If that bench mark (r1) is not surpassed at the end of stage 1 (n1), then the trial ends
with the treatment considered inadequate and abandoned (rejection).
- In the second stage, the total sample size, including those already
collected in stage 1, is defined (nTot), and a second and final bench mark for the total number of
successes, including those already collected in stage 1, is defined (rTot). once
the number of successes surpassed rTot, the trial can terminate and the treatment
considered worthy of further evaluation at the Phase III or control trial level (acceptance).
If rTot is not surpassed after nTot cases, then the trial terminates, and the
treatment considered inadequate and abandoned (rejection).
Simon's procedure therefore has advantages over Fleming's Procedures as in the Sample Size for Phase II Study (Fleming's Procedure) Explained and Tables Page
and Gehan's Procedure as in the Sample Size for Phase II Study (Gehan's Procedure) Explained and Tables Page
, in that the sample size is not fixed, and the
trial can terminate early if the results are obvious. It is particularly effective in rejecting new treatments with
below expectation proportion of successes.
Parameters : The following parameters are required
- Probability of Type I Error (α), in most cases 0.05 is used
- Power (1-β) where β is the Probability of type II Error, in most cases 0.8 or 0.9 are used
- The base line proportion of success (p0)
- The proportion of success we required to accept the new treatment (p1)
Results : The programs produces the following results
- The maximum sample size for stage 1 (n1)
- The number of success required in stage 1, above which stage 2 is entered, and at or below which after n1 cases results in
terminating the trial with rejection of the treatment
- The total maximum sample size (nTot), inclusive of both stages
- The total number of success required (rTot), inclusive of both stages, above which resulting in terminating the trial with
acceptance of the treatment for further trials, and below which after nTot cases results in rejection of the treatment
- The average expected number of cases (EN) for a decision
- The probability of early termination of the study (PET) if the true success rate is below requirements
Models : Simon's Procedure produces two alternative results, based on different statistical assumptions.
- The minimax model requires a smaller overall sample size (EN), so is preferred if the researcher
is optimistic about the treatment being tested, hoping to require a smaller overall sample size to validate its
acceptance for further trials
- The Optimal model has a smaller sample size for stage 1 and more likely to terminate early (PET) if the true success rate
is below requirement, so is preferred for early screening of new treatments to exclude those without potentials from
expensive further study.
Simon's procedure uses iterative approximations to find the sample size required
for the two stages. The iterations are several layers deep, and involved the
calculation of binomial coefficients, so that the time required for calculation
increases exponentially as the sample size being considered increases.
In most cases, where the success rate required is below 0.8 (80%), and when the acceptance
and rejection levels differ more than 0.15 (15%), the sample size required is less than 60,
and the time required for calculation is acceptably short.
With higher success rates required, or where the difference in proportions between rejection and acceptance
is narrower, the sample size increases dramatically, and when sample size is over 100
the calculation time can be several minutes.
The Internet server, which imposes a limit to processing time, is therefore not able to
support this calculation. This page therefore provides two facilities for this procedure.
- Tables for sample size for powers of 0.8 and 0.9, for Probability of Type I Error (α) of 0.1, 0.05, and 0.01,
and for p0 and p1 at various intervals are provided. The tables include all calculations where the total sample
size is less than 80, and the time limit of computation set at 2 minutes (using php on XAMPP, lap top computer).
- A small calculator in Javascript is provided for situations not covered in the tables. The user
should however be aware that, should the sample size required exceeds those in the tables already provided, the processing
time will be prolonged, and the web page appears frozen.
Please also note that some browsers have time limits, and when that limit is reached it asks the user whether to continue or not.
Although long programs can be run, it does require the user to attend and repeatedly tell the browser to continue.
The limits are as follows.
- Internet Explorer - 5 million statements
- Firefox - 10 secs
- Safari - 5 secs
- Chrome - no time limit
- Opera - no time limit
A particular cancer, with the current available treatment, has a five year survival rate of 10%.
A new drug is developed which looks promising, and we wish to conduct a Phase II trial. We decided that
if the new drug can improve survival to 40% in a phase II trial, then it is worth the expense
of develop this drug and test it in a large phase III trial (acceptance of the treatment). However, if the
survival rate is no better than 40%, then the new drug should be rejected from
further development (rejection of the treatment). We decided to use α of 0.05, and power of 0.8 in such a study.
| r1 | n1 | rTot | nTot | EN | PET |
minimax | 1 | 8 | 3 | 13 | 9 | 0.81 |
Optimal | 0 | 4 | 3 | 15 | 8 | 0.66 |
The parameters are therefore α=0.05, (1-β)=0.8, p0 = 0.1, and p1=0.4. The results
are as in the table to the right.
The following are the possible scenarios after, the minimax model is used to demonstrate
- Stage 1. n1 = 8, r1 = 1
- If no more than 1 case survived (success<=1) in the first 8 cases,
the treatment is abandoned (treatment rejection) at the end of stage 1. End of study
- With the second survival (success>1) anytime within the first 8 cases, the trial enters the second stage
- Stage 2. nTot = 13, rTot = 3
- Including the data from stage 1, if there are 3 or less survivals (successes<=3) at the end of 13 cases,
the treatment is abandoned (treatment rejection) as not worthy of further development. End of study.
- On the 4th survival (>3 successes, 2 in stage 2 plus the 2 from stage 1) any time before 13 cases are studied,
the treatment is declared worthy of further development, go onto Phase III trial, etc, (treatment acceptance). End of study.
- We expect that, if the true success rate is 40% or more, we need and average of 9 (EN=9) cases to decide accepting the treatment.
If the true success rate is less than 40%, we have 81% chance (PET=0.81) of rejecting the treatment
Power=0.8
Power=0.9
| | alpha=0.1 | alpha=0.05 | alpha=0.01 |
| | Minmax | Optimal | Minmax | Optimal | Minmax | Optimal |
p0 | p1 | r1 | n1 | rTot | nTot | EN | PET | r1 | n1 | rTot | nTot | EN | PET | r1 | n1 | rTot | nTot | EN | PET | r1 | n1 | rTot | nTot | EN | PET | r1 | n1 | rTot | nTot | EN | PET | r1 | n1 | rTot | nTot | EN | PET |
0.05 | 0.15 | 1 | 29 | 4 | 44 | 36 | 0.57 | 1 | 20 | 4 | 56 | 30 | 0.74 | 1 | 24 | 5 | 55 | 35 | 0.66 | 1 | 23 | 5 | 56 | 34 | 0.68 | 2 | 42 | 10 | 90 | 59 | 0.65 | 2 | 31 | 10 | 99 | 45 | 0.80 |
0.05 | 0.2 | 0 | 12 | 2 | 21 | 17 | 0.54 | 0 | 9 | 2 | 24 | 15 | 0.63 | 1 | 16 | 3 | 30 | 19 | 0.81 | 1 | 16 | 3 | 30 | 19 | 0.81 | 1 | 17 | 6 | 48 | 24 | 0.79 | 1 | 16 | 6 | 50 | 23 | 0.81 |
0.05 | 0.25 | 0 | 12 | 2 | 16 | 14 | 0.54 | 0 | 6 | 2 | 23 | 11 | 0.74 | 1 | 12 | 2 | 19 | 13 | 0.88 | 0 | 6 | 3 | 29 | 13 | 0.74 | 1 | 16 | 5 | 31 | 19 | 0.81 | 1 | 12 | 5 | 36 | 15 | 0.88 |
0.05 | 0.3 | 0 | 6 | 1 | 10 | 8 | 0.74 | 0 | 5 | 1 | 12 | 7 | 0.77 | 0 | 7 | 2 | 14 | 10 | 0.70 | 0 | 5 | 2 | 18 | 8 | 0.77 | 0 | 7 | 4 | 23 | 12 | 0.70 | 0 | 5 | 4 | 27 | 10 | 0.77 |
0.05 | 0.35 | 0 | 6 | 1 | 8 | 7 | 0.74 | 0 | 4 | 1 | 11 | 6 | 0.81 | 0 | 6 | 2 | 12 | 8 | 0.74 | 0 | 4 | 2 | 16 | 7 | 0.81 | 0 | 5 | 3 | 17 | 8 | 0.77 | 0 | 4 | 4 | 24 | 8 | 0.81 |
0.05 | 0.4 | 0 | 5 | 1 | 7 | 6 | 0.77 | 0 | 4 | 1 | 8 | 5 | 0.81 | 0 | 4 | 1 | 8 | 5 | 0.81 | 0 | 4 | 1 | 8 | 5 | 0.81 | 0 | 5 | 3 | 14 | 8 | 0.77 | 0 | 4 | 3 | 15 | 7 | 0.81 |
0.05 | 0.45 | 0 | 4 | 1 | 6 | 5 | 0.81 | 0 | 3 | 1 | 8 | 4 | 0.86 | 0 | 4 | 1 | 7 | 5 | 0.81 | 0 | 3 | 1 | 8 | 4 | 0.86 | 1 | 6 | 2 | 11 | 7 | 0.97 | 0 | 3 | 3 | 14 | 5 | 0.86 |
0.05 | 0.5 | 0 | 4 | 1 | 5 | 5 | 0.81 | 0 | 3 | 1 | 6 | 4 | 0.86 | 0 | 3 | 1 | 6 | 4 | 0.86 | 0 | 3 | 1 | 6 | 4 | 0.86 | 0 | 3 | 2 | 9 | 4 | 0.86 | 0 | 3 | 2 | 9 | 4 | 0.86 |
0.1 | 0.2 | 6 | 47 | 8 | 57 | 49 | 0.81 | 2 | 24 | 9 | 65 | 42 | 0.56 | 4 | 45 | 12 | 78 | 61 | 0.53 | 3 | 30 | 13 | 89 | 51 | 0.65 | 0 | 0 | 0 | 0 | 0 | 0.00 | 0 | 0 | 0 | 0 | 0 | 0.00 |
0.1 | 0.25 | 1 | 16 | 5 | 31 | 24 | 0.51 | 1 | 13 | 5 | 34 | 21 | 0.62 | 2 | 22 | 7 | 40 | 29 | 0.62 | 2 | 18 | 7 | 43 | 25 | 0.73 | 3 | 26 | 12 | 64 | 36 | 0.74 | 3 | 22 | 14 | 80 | 32 | 0.83 |
0.1 | 0.3 | 0 | 7 | 3 | 18 | 13 | 0.48 | 0 | 7 | 3 | 18 | 13 | 0.48 | 1 | 15 | 5 | 25 | 20 | 0.55 | 1 | 10 | 5 | 29 | 16 | 0.74 | 3 | 25 | 9 | 40 | 29 | 0.76 | 2 | 14 | 9 | 46 | 20 | 0.84 |
0.1 | 0.35 | 1 | 9 | 2 | 12 | 10 | 0.77 | 1 | 8 | 2 | 13 | 9 | 0.81 | 1 | 11 | 4 | 18 | 14 | 0.70 | 1 | 8 | 4 | 22 | 11 | 0.81 | 2 | 15 | 7 | 28 | 18 | 0.82 | 1 | 8 | 8 | 37 | 14 | 0.81 |
0.1 | 0.4 | 0 | 5 | 2 | 10 | 8 | 0.59 | 0 | 4 | 2 | 11 | 7 | 0.66 | 1 | 8 | 3 | 13 | 9 | 0.81 | 0 | 4 | 3 | 15 | 8 | 0.66 | 1 | 8 | 5 | 20 | 11 | 0.81 | 1 | 7 | 6 | 25 | 10 | 0.85 |
0.1 | 0.45 | 0 | 4 | 2 | 9 | 6 | 0.66 | 0 | 3 | 2 | 11 | 6 | 0.73 | 1 | 6 | 2 | 10 | 7 | 0.89 | 0 | 3 | 3 | 14 | 6 | 0.73 | 1 | 10 | 5 | 16 | 12 | 0.74 | 1 | 6 | 5 | 19 | 8 | 0.89 |
0.1 | 0.5 | 0 | 4 | 1 | 5 | 5 | 0.66 | 0 | 3 | 1 | 6 | 4 | 0.73 | 0 | 4 | 2 | 8 | 6 | 0.66 | 0 | 3 | 2 | 9 | 5 | 0.73 | 1 | 6 | 4 | 13 | 7 | 0.89 | 1 | 5 | 4 | 16 | 6 | 0.92 |
0.1 | 0.55 | 0 | 3 | 1 | 5 | 4 | 0.73 | 0 | 3 | 1 | 5 | 4 | 0.73 | 0 | 3 | 2 | 7 | 5 | 0.73 | 0 | 3 | 2 | 7 | 5 | 0.73 | 1 | 5 | 3 | 10 | 6 | 0.92 | 1 | 5 | 3 | 10 | 6 | 0.92 |
0.1 | 0.6 | 0 | 3 | 1 | 4 | 4 | 0.73 | 0 | 2 | 1 | 5 | 3 | 0.81 | 0 | 3 | 2 | 6 | 4 | 0.73 | 0 | 2 | 2 | 8 | 4 | 0.81 | 0 | 3 | 3 | 9 | 5 | 0.73 | 0 | 2 | 3 | 10 | 4 | 0.81 |
0.15 | 0.3 | 2 | 18 | 8 | 37 | 28 | 0.48 | 3 | 19 | 8 | 39 | 26 | 0.68 | 3 | 23 | 11 | 48 | 35 | 0.54 | 3 | 19 | 12 | 55 | 31 | 0.68 |
0.15 | 0.35 | 1 | 10 | 5 | 22 | 16 | 0.54 | 1 | 9 | 5 | 23 | 15 | 0.60 | 2 | 15 | 7 | 28 | 21 | 0.60 | 1 | 9 | 8 | 34 | 20 | 0.60 |
0.15 | 0.4 | 1 | 9 | 4 | 16 | 12 | 0.60 | 1 | 7 | 4 | 18 | 11 | 0.72 | 1 | 9 | 5 | 19 | 14 | 0.60 | 1 | 7 | 6 | 25 | 13 | 0.72 | 8 | 27 | 9 | 32 | 28 | 0.99 | 2 | 10 | 11 | 41 | 16 | 0.82 |
0.15 | 0.45 | 1 | 8 | 3 | 11 | 10 | 0.66 | 1 | 6 | 3 | 13 | 8 | 0.78 | 0 | 5 | 4 | 14 | 11 | 0.44 | 1 | 6 | 5 | 19 | 9 | 0.78 | 6 | 19 | 7 | 23 | 20 | 0.98 | 2 | 9 | 8 | 27 | 12 | 0.86 |
0.15 | 0.5 | 0 | 4 | 2 | 8 | 6 | 0.52 | 0 | 4 | 2 | 8 | 6 | 0.52 | 1 | 8 | 4 | 12 | 10 | 0.66 | 1 | 5 | 4 | 16 | 7 | 0.84 | 1 | 7 | 6 | 17 | 10 | 0.72 | 1 | 5 | 8 | 27 | 9 | 0.84 |
0.15 | 0.55 | 0 | 3 | 2 | 7 | 5 | 0.61 | 0 | 3 | 2 | 7 | 5 | 0.61 | 0 | 4 | 3 | 9 | 7 | 0.52 | 0 | 3 | 3 | 10 | 6 | 0.61 | 1 | 5 | 5 | 14 | 7 | 0.84 | 1 | 5 | 5 | 14 | 7 | 0.84 |
0.15 | 0.6 | 0 | 3 | 2 | 6 | 5 | 0.61 | 0 | 2 | 2 | 8 | 4 | 0.72 | 0 | 3 | 3 | 8 | 5 | 0.61 | 0 | 2 | 3 | 10 | 5 | 0.72 | 3 | 8 | 4 | 11 | 9 | 0.98 | 1 | 4 | 5 | 15 | 6 | 0.89 |
0.15 | 0.65 | 0 | 2 | 1 | 4 | 3 | 0.72 | 0 | 2 | 1 | 4 | 3 | 0.72 | 0 | 2 | 2 | 6 | 4 | 0.72 | 0 | 2 | 2 | 6 | 4 | 0.72 | 0 | 3 | 4 | 9 | 6 | 0.61 | 0 | 2 | 4 | 10 | 5 | 0.72 |
0.2 | 0.4 | 2 | 14 | 7 | 24 | 20 | 0.45 | 2 | 12 | 7 | 25 | 18 | 0.56 | 4 | 18 | 10 | 33 | 23 | 0.72 | 3 | 13 | 12 | 43 | 21 | 0.75 |
0.2 | 0.45 | 1 | 10 | 5 | 16 | 14 | 0.38 | 1 | 7 | 5 | 17 | 12 | 0.58 | 2 | 13 | 7 | 21 | 17 | 0.50 | 2 | 10 | 7 | 22 | 14 | 0.68 |
0.2 | 0.5 | 1 | 8 | 4 | 12 | 10 | 0.50 | 1 | 6 | 4 | 13 | 9 | 0.66 | 2 | 9 | 6 | 17 | 12 | 0.74 | 2 | 8 | 6 | 18 | 11 | 0.80 | 3 | 12 | 10 | 26 | 15 | 0.79 | 2 | 8 | 11 | 31 | 13 | 0.80 |
0.2 | 0.55 | 0 | 4 | 3 | 9 | 7 | 0.41 | 1 | 5 | 3 | 10 | 7 | 0.74 | 1 | 6 | 4 | 11 | 8 | 0.66 | 1 | 5 | 5 | 14 | 8 | 0.74 | 2 | 9 | 8 | 19 | 12 | 0.74 | 2 | 7 | 9 | 24 | 10 | 0.85 |
0.2 | 0.6 | 0 | 3 | 2 | 6 | 5 | 0.51 | 0 | 3 | 2 | 6 | 5 | 0.51 | 1 | 5 | 4 | 10 | 7 | 0.74 | 1 | 4 | 4 | 12 | 6 | 0.82 | 1 | 5 | 7 | 16 | 8 | 0.74 | 1 | 4 | 8 | 21 | 8 | 0.82 |
0.2 | 0.65 | 0 | 2 | 2 | 6 | 4 | 0.64 | 0 | 2 | 2 | 6 | 4 | 0.64 | 1 | 5 | 3 | 7 | 6 | 0.74 | 0 | 2 | 3 | 8 | 5 | 0.64 | 2 | 6 | 6 | 13 | 7 | 0.90 | 1 | 4 | 6 | 14 | 6 | 0.82 |
0.2 | 0.7 | 0 | 2 | 2 | 5 | 4 | 0.64 | 0 | 2 | 2 | 5 | 4 | 0.64 | 0 | 2 | 3 | 7 | 4 | 0.64 | 0 | 2 | 3 | 7 | 4 | 0.64 | 0 | 2 | 5 | 10 | 5 | 0.64 | 0 | 2 | 5 | 10 | 5 | 0.64 |
0.25 | 0.45 | 3 | 15 | 9 | 26 | 21 | 0.46 | 4 | 15 | 9 | 27 | 19 | 0.69 | 4 | 17 | 13 | 36 | 26 | 0.57 | 5 | 17 | 14 | 41 | 23 | 0.77 |
0.25 | 0.5 | 2 | 9 | 6 | 17 | 13 | 0.60 | 2 | 8 | 7 | 21 | 13 | 0.68 | 2 | 9 | 9 | 24 | 15 | 0.60 | 2 | 9 | 9 | 24 | 15 | 0.60 |
0.25 | 0.55 | 1 | 6 | 5 | 13 | 10 | 0.53 | 1 | 5 | 5 | 14 | 9 | 0.63 | 2 | 9 | 7 | 17 | 13 | 0.60 | 2 | 7 | 8 | 21 | 11 | 0.76 | 2 | 9 | 12 | 27 | 17 | 0.60 | 2 | 7 | 14 | 34 | 14 | 0.76 |
0.25 | 0.6 | 1 | 5 | 4 | 10 | 7 | 0.63 | 1 | 5 | 4 | 10 | 7 | 0.63 | 1 | 5 | 5 | 12 | 8 | 0.63 | 1 | 5 | 5 | 12 | 8 | 0.63 | 2 | 8 | 10 | 21 | 13 | 0.68 | 2 | 6 | 12 | 29 | 10 | 0.83 |
0.25 | 0.65 | 1 | 5 | 3 | 7 | 6 | 0.63 | 0 | 2 | 3 | 8 | 5 | 0.56 | 0 | 3 | 4 | 9 | 7 | 0.42 | 1 | 4 | 5 | 12 | 7 | 0.74 | 3 | 8 | 8 | 16 | 9 | 0.89 | 1 | 4 | 8 | 17 | 8 | 0.74 |
0.25 | 0.7 | 0 | 2 | 2 | 5 | 4 | 0.56 | 0 | 2 | 2 | 5 | 4 | 0.56 | 0 | 3 | 4 | 8 | 6 | 0.42 | 0 | 2 | 4 | 9 | 6 | 0.56 | 2 | 6 | 7 | 13 | 8 | 0.83 | 2 | 5 | 8 | 16 | 7 | 0.90 |
0.25 | 0.75 | 1 | 3 | 2 | 5 | 4 | 0.84 | 1 | 3 | 2 | 5 | 4 | 0.84 | 0 | 2 | 3 | 6 | 4 | 0.56 | 1 | 3 | 3 | 7 | 4 | 0.84 | 2 | 5 | 6 | 11 | 6 | 0.90 | 1 | 3 | 6 | 12 | 5 | 0.84 |
0.3 | 0.55 | 5 | 14 | 7 | 17 | 15 | 0.78 | 2 | 8 | 8 | 20 | 14 | 0.55 | 2 | 9 | 11 | 25 | 18 | 0.46 | 3 | 9 | 14 | 35 | 16 | 0.73 |
0.3 | 0.6 | 4 | 10 | 5 | 12 | 11 | 0.85 | 1 | 5 | 6 | 14 | 10 | 0.53 | 2 | 10 | 8 | 17 | 15 | 0.38 | 3 | 8 | 10 | 24 | 12 | 0.81 |
0.3 | 0.65 | 2 | 6 | 4 | 9 | 7 | 0.74 | 2 | 6 | 4 | 9 | 7 | 0.74 | 2 | 7 | 7 | 14 | 10 | 0.65 | 1 | 4 | 7 | 15 | 8 | 0.65 | 4 | 10 | 11 | 21 | 12 | 0.85 | 2 | 6 | 12 | 24 | 11 | 0.74 |
0.3 | 0.7 | 2 | 5 | 3 | 7 | 6 | 0.84 | 2 | 5 | 3 | 7 | 6 | 0.84 | 0 | 2 | 5 | 10 | 7 | 0.49 | 0 | 2 | 5 | 10 | 7 | 0.49 | 2 | 6 | 9 | 16 | 9 | 0.74 | 2 | 5 | 11 | 21 | 8 | 0.84 |
0.3 | 0.75 | 0 | 2 | 3 | 6 | 5 | 0.49 | 1 | 3 | 3 | 7 | 4 | 0.78 | 2 | 5 | 4 | 8 | 6 | 0.84 | 1 | 3 | 5 | 10 | 5 | 0.78 | 2 | 5 | 7 | 12 | 7 | 0.84 | 1 | 3 | 9 | 17 | 7 | 0.78 |
0.3 | 0.8 | 0 | 2 | 2 | 4 | 4 | 0.49 | 0 | 2 | 2 | 4 | 4 | 0.49 | 2 | 4 | 3 | 6 | 5 | 0.92 | 1 | 3 | 4 | 7 | 4 | 0.78 | 1 | 3 | 6 | 10 | 5 | 0.78 | 1 | 3 | 6 | 10 | 5 | 0.78 |
0.3 | 0.85 | 0 | 2 | 2 | 4 | 4 | 0.49 | 0 | 1 | 3 | 6 | 3 | 0.70 | 1 | 3 | 3 | 5 | 4 | 0.78 | 0 | 1 | 3 | 6 | 3 | 0.70 | 2 | 4 | 5 | 8 | 5 | 0.92 | 0 | 1 | 6 | 10 | 4 | 0.70 |
0.3 | 0.9 | 0 | 1 | 2 | 4 | 2 | 0.70 | 0 | 1 | 2 | 4 | 2 | 0.70 | 1 | 2 | 2 | 4 | 3 | 0.91 | 1 | 2 | 2 | 4 | 3 | 0.91 | 0 | 1 | 4 | 6 | 3 | 0.70 | 0 | 1 | 4 | 6 | 3 | 0.70 |
0.35 | 0.6 | 4 | 13 | 8 | 17 | 15 | 0.50 | 4 | 10 | 10 | 23 | 14 | 0.75 | 6 | 18 | 13 | 26 | 22 | 0.55 | 3 | 9 | 13 | 27 | 16 | 0.61 |
0.35 | 0.65 | 2 | 7 | 7 | 14 | 11 | 0.53 | 1 | 4 | 7 | 15 | 9 | 0.56 | 8 | 16 | 9 | 18 | 17 | 0.93 | 2 | 6 | 10 | 20 | 11 | 0.65 |
0.35 | 0.7 | 0 | 2 | 5 | 10 | 7 | 0.42 | 0 | 2 | 5 | 10 | 7 | 0.42 | 2 | 6 | 7 | 13 | 9 | 0.65 | 2 | 5 | 8 | 16 | 8 | 0.76 | 4 | 9 | 12 | 21 | 12 | 0.83 | 3 | 7 | 13 | 23 | 11 | 0.80 |
0.35 | 0.75 | 0 | 2 | 4 | 8 | 6 | 0.42 | 1 | 3 | 5 | 10 | 5 | 0.72 | 2 | 5 | 5 | 9 | 6 | 0.76 | 1 | 3 | 7 | 13 | 6 | 0.72 | 7 | 12 | 9 | 15 | 13 | 0.97 | 3 | 6 | 12 | 21 | 8 | 0.88 |
0.35 | 0.8 | 1 | 3 | 3 | 6 | 4 | 0.72 | 1 | 3 | 3 | 6 | 4 | 0.72 | 1 | 3 | 4 | 7 | 5 | 0.72 | 1 | 3 | 4 | 7 | 5 | 0.72 | 4 | 7 | 8 | 13 | 8 | 0.94 | 2 | 4 | 10 | 17 | 6 | 0.87 |
0.35 | 0.85 | 1 | 3 | 3 | 5 | 4 | 0.72 | 0 | 1 | 3 | 6 | 3 | 0.65 | 0 | 1 | 4 | 7 | 4 | 0.65 | 0 | 1 | 4 | 7 | 4 | 0.65 | 2 | 4 | 6 | 9 | 5 | 0.87 | 0 | 1 | 7 | 11 | 5 | 0.65 |
0.35 | 0.9 | 0 | 1 | 2 | 4 | 3 | 0.65 | 0 | 1 | 2 | 4 | 3 | 0.65 | 0 | 1 | 3 | 5 | 3 | 0.65 | 0 | 1 | 3 | 5 | 3 | 0.65 | 1 | 3 | 5 | 7 | 5 | 0.72 | 1 | 2 | 7 | 11 | 4 | 0.88 |
0.35 | 0.95 | 0 | 1 | 2 | 3 | 2 | 0.65 | 0 | 1 | 2 | 3 | 2 | 0.65 | 0 | 1 | 2 | 3 | 2 | 0.65 | 0 | 1 | 2 | 3 | 2 | 0.65 | 3 | 4 | 4 | 6 | 5 | 0.98 | 1 | 2 | 5 | 7 | 3 | 0.88 |
0.4 | 0.65 | 3 | 9 | 10 | 19 | 15 | 0.48 | 5 | 11 | 10 | 20 | 14 | 0.75 | 5 | 12 | 14 | 26 | 17 | 0.67 | 5 | 11 | 16 | 31 | 16 | 0.75 |
0.4 | 0.7 | 2 | 6 | 7 | 13 | 10 | 0.54 | 2 | 5 | 8 | 16 | 9 | 0.68 | 6 | 12 | 10 | 18 | 13 | 0.84 | 3 | 7 | 11 | 20 | 11 | 0.71 |
0.4 | 0.75 | 2 | 5 | 5 | 9 | 7 | 0.68 | 2 | 5 | 5 | 9 | 7 | 0.68 | 2 | 5 | 8 | 14 | 8 | 0.68 | 2 | 5 | 8 | 14 | 8 | 0.68 | 9 | 15 | 13 | 21 | 16 | 0.97 | 3 | 6 | 16 | 27 | 10 | 0.82 |
0.4 | 0.8 | 1 | 3 | 4 | 7 | 5 | 0.65 | 1 | 3 | 4 | 7 | 5 | 0.65 | 1 | 3 | 6 | 10 | 6 | 0.65 | 1 | 3 | 6 | 10 | 6 | 0.65 | 2 | 5 | 10 | 15 | 9 | 0.68 | 2 | 4 | 14 | 23 | 8 | 0.82 |
0.4 | 0.85 | 1 | 3 | 3 | 5 | 4 | 0.65 | 0 | 1 | 4 | 7 | 4 | 0.60 | 2 | 4 | 5 | 8 | 5 | 0.82 | 0 | 1 | 6 | 10 | 5 | 0.60 | 7 | 10 | 8 | 12 | 11 | 0.99 | 2 | 4 | 9 | 13 | 6 | 0.82 |
0.4 | 0.9 | 0 | 1 | 3 | 5 | 3 | 0.60 | 0 | 1 | 3 | 5 | 3 | 0.60 | 0 | 1 | 4 | 6 | 3 | 0.60 | 0 | 1 | 4 | 6 | 3 | 0.60 | 3 | 5 | 7 | 10 | 6 | 0.91 | 1 | 2 | 9 | 14 | 4 | 0.84 |
0.4 | 0.95 | 0 | 1 | 2 | 3 | 2 | 0.60 | 0 | 1 | 2 | 3 | 2 | 0.60 | 0 | 1 | 3 | 4 | 3 | 0.60 | 0 | 1 | 3 | 4 | 3 | 0.60 | 3 | 4 | 5 | 7 | 5 | 0.97 | 1 | 2 | 6 | 8 | 3 | 0.84 |
0.45 | 0.7 | 3 | 8 | 11 | 19 | 14 | 0.48 | 5 | 10 | 11 | 20 | 13 | 0.74 | 5 | 12 | 15 | 25 | 19 | 0.53 | 5 | 10 | 19 | 33 | 16 | 0.74 |
0.45 | 0.75 | 2 | 5 | 7 | 12 | 8 | 0.59 | 2 | 5 | 7 | 12 | 8 | 0.59 | 2 | 6 | 10 | 16 | 12 | 0.44 | 2 | 5 | 11 | 18 | 11 | 0.59 |
0.45 | 0.8 | 1 | 3 | 6 | 10 | 6 | 0.57 | 1 | 3 | 6 | 10 | 6 | 0.57 | 7 | 11 | 8 | 13 | 12 | 0.94 | 1 | 3 | 9 | 14 | 8 | 0.57 |
0.45 | 0.85 | 3 | 5 | 4 | 7 | 6 | 0.87 | 2 | 4 | 5 | 8 | 5 | 0.76 | 2 | 4 | 6 | 9 | 6 | 0.76 | 2 | 4 | 6 | 9 | 6 | 0.76 | 6 | 9 | 10 | 14 | 10 | 0.95 | 3 | 5 | 13 | 19 | 7 | 0.87 |
0.45 | 0.9 | 0 | 1 | 4 | 6 | 4 | 0.55 | 1 | 2 | 4 | 7 | 4 | 0.80 | 1 | 3 | 5 | 7 | 5 | 0.57 | 1 | 2 | 7 | 11 | 4 | 0.80 | 5 | 7 | 8 | 11 | 8 | 0.96 | 1 | 2 | 11 | 16 | 5 | 0.80 |
0.45 | 0.95 | 0 | 1 | 2 | 3 | 2 | 0.55 | 0 | 1 | 2 | 3 | 2 | 0.55 | 1 | 2 | 4 | 6 | 3 | 0.80 | 1 | 2 | 4 | 6 | 3 | 0.80 | 3 | 4 | 6 | 8 | 5 | 0.96 | 1 | 2 | 7 | 9 | 4 | 0.80 |
0.5 | 0.75 | 9 | 15 | 11 | 18 | 16 | 0.85 | 5 | 9 | 13 | 22 | 13 | 0.75 | 7 | 14 | 15 | 23 | 18 | 0.60 | 6 | 11 | 16 | 25 | 15 | 0.73 |
0.5 | 0.8 | 4 | 7 | 8 | 13 | 9 | 0.77 | 4 | 7 | 8 | 13 | 9 | 0.77 | 10 | 15 | 11 | 17 | 16 | 0.94 | 4 | 7 | 13 | 20 | 10 | 0.77 |
0.5 | 0.85 | 2 | 4 | 6 | 9 | 6 | 0.69 | 2 | 4 | 6 | 9 | 6 | 0.69 | 7 | 10 | 8 | 12 | 11 | 0.95 | 2 | 4 | 9 | 13 | 7 | 0.69 | 5 | 8 | 14 | 19 | 10 | 0.86 | 3 | 5 | 17 | 24 | 9 | 0.81 |
0.5 | 0.9 | 0 | 1 | 4 | 6 | 4 | 0.50 | 0 | 1 | 4 | 6 | 4 | 0.50 | 2 | 4 | 6 | 8 | 6 | 0.69 | 1 | 2 | 9 | 14 | 5 | 0.75 | 4 | 6 | 10 | 13 | 7 | 0.89 | 3 | 5 | 11 | 14 | 7 | 0.81 |
0.5 | 0.95 | 1 | 2 | 3 | 4 | 3 | 0.75 | 1 | 2 | 3 | 4 | 3 | 0.75 | 3 | 4 | 4 | 6 | 5 | 0.94 | 1 | 2 | 5 | 7 | 4 | 0.75 | 2 | 3 | 8 | 10 | 4 | 0.88 | 2 | 3 | 8 | 10 | 4 | 0.88 |
0.55 | 0.8 | 3 | 6 | 12 | 18 | 12 | 0.56 | 4 | 7 | 13 | 20 | 12 | 0.68 | 5 | 9 | 16 | 23 | 15 | 0.64 | 4 | 7 | 19 | 28 | 14 | 0.68 |
0.55 | 0.85 | 1 | 3 | 7 | 10 | 8 | 0.43 | 3 | 5 | 8 | 12 | 7 | 0.74 | 4 | 7 | 11 | 15 | 10 | 0.68 | 3 | 5 | 14 | 20 | 9 | 0.74 |
0.55 | 0.9 | 2 | 4 | 6 | 8 | 6 | 0.61 | 2 | 4 | 6 | 8 | 6 | 0.61 | 5 | 7 | 8 | 11 | 8 | 0.90 | 3 | 5 | 9 | 12 | 7 | 0.74 | 12 | 15 | 13 | 17 | 16 | 0.99 | 4 | 6 | 14 | 18 | 8 | 0.84 |
0.55 | 0.95 | 2 | 3 | 4 | 6 | 4 | 0.83 | 2 | 3 | 4 | 6 | 4 | 0.83 | 1 | 2 | 6 | 8 | 4 | 0.70 | 1 | 2 | 6 | 8 | 4 | 0.70 | 1 | 2 | 10 | 12 | 6 | 0.70 | 3 | 4 | 11 | 14 | 5 | 0.91 |
0.6 | 0.85 | 4 | 7 | 11 | 15 | 11 | 0.58 | 3 | 5 | 14 | 20 | 11 | 0.66 | 4 | 7 | 15 | 20 | 12.5 | 0.5801 | 6 | 9 | 17 | 23 | 12.2 | 0.7682 |
0.6 | 0.9 | 6 | 8 | 7 | 10 | 9 | 0.89 | 4 | 6 | 8 | 11 | 8 | 0.77 | 4 | 6 | 10 | 13 | 8 | 0.77 | 4 | 6 | 10 | 13 | 8 | 0.77 |
0.6 | 0.95 | 3 | 4 | 5 | 7 | 5 | 0.87 | 2 | 3 | 6 | 8 | 5 | 0.78 | 2 | 3 | 8 | 10 | 5 | 0.78 | 2 | 3 | 8 | 10 | 5 | 0.78 | 4 | 6 | 12 | 14 | 8 | 0.77 | 2 | 3 | 14 | 17 | 7 | 0.78 |
| | alpha=0.1 | alpha=0.05 |
| | Minmax | Optimal | Minmax | Optimal |
p0 | p1 | r1 | n1 | rTot | nTot | EN | PET | r1 | n1 | rTot | nTot | EN | PET | r1 | n1 | rTot | nTot | EN | PET | r1 | n1 | rTot | nTot | EN | PET |
0.05 | 0.2 | 0 | 18 | 3 | 32 | 27 | 0.40 | 0 | 12 | 3 | 37 | 24 | 0.54 | 1 | 21 | 4 | 41 | 27 | 0.72 | 1 | 21 | 4 | 41 | 27 | 0.72 |
0.05 | 0.25 | 0 | 13 | 2 | 20 | 17 | 0.51 | 0 | 9 | 2 | 24 | 15 | 0.63 | 0 | 11 | 3 | 27 | 18 | 0.57 | 0 | 9 | 3 | 30 | 17 | 0.63 |
0.05 | 0.3 | 0 | 13 | 2 | 16 | 15 | 0.51 | 0 | 7 | 2 | 21 | 12 | 0.70 | 1 | 12 | 2 | 19 | 13 | 0.88 | 0 | 7 | 3 | 26 | 13 | 0.70 |
0.05 | 0.35 | 0 | 7 | 1 | 11 | 9 | 0.70 | 0 | 6 | 1 | 12 | 8 | 0.74 | 0 | 7 | 2 | 15 | 10 | 0.70 | 0 | 6 | 2 | 17 | 9 | 0.74 |
0.05 | 0.4 | 0 | 6 | 1 | 9 | 7 | 0.74 | 0 | 5 | 1 | 10 | 7 | 0.77 | 0 | 7 | 2 | 12 | 9 | 0.70 | 0 | 5 | 2 | 14 | 8 | 0.77 |
0.05 | 0.45 | 0 | 5 | 1 | 8 | 6 | 0.77 | 0 | 4 | 1 | 10 | 6 | 0.81 | 0 | 8 | 2 | 10 | 9 | 0.66 | 0 | 4 | 2 | 14 | 6 | 0.81 |
0.05 | 0.5 | 0 | 4 | 1 | 7 | 5 | 0.81 | 0 | 4 | 1 | 7 | 5 | 0.81 | 0 | 4 | 1 | 8 | 5 | 0.81 | 0 | 4 | 1 | 8 | 5 | 0.81 |
0.1 | 0.3 | 2 | 18 | 4 | 26 | 21 | 0.73 | 1 | 12 | 5 | 35 | 20 | 0.66 | 2 | 19 | 6 | 34 | 24 | 0.71 | 2 | 18 | 6 | 35 | 23 | 0.73 |
0.1 | 0.35 | 0 | 8 | 3 | 18 | 14 | 0.43 | 1 | 11 | 3 | 19 | 14 | 0.70 | 1 | 13 | 5 | 25 | 18 | 0.62 | 1 | 11 | 5 | 27 | 16 | 0.70 |
0.1 | 0.4 | 0 | 8 | 3 | 15 | 12 | 0.43 | 0 | 5 | 3 | 18 | 11 | 0.59 | 1 | 12 | 4 | 18 | 15 | 0.66 | 1 | 9 | 4 | 20 | 12 | 0.77 |
0.1 | 0.45 | 0 | 8 | 2 | 10 | 10 | 0.43 | 0 | 5 | 2 | 11 | 8 | 0.59 | 0 | 7 | 3 | 13 | 11 | 0.48 | 0 | 5 | 3 | 14 | 9 | 0.59 |
0.1 | 0.5 | 0 | 5 | 2 | 9 | 7 | 0.59 | 0 | 4 | 2 | 10 | 7 | 0.66 | 0 | 5 | 3 | 12 | 8 | 0.59 | 0 | 4 | 3 | 13 | 8 | 0.66 |
0.1 | 0.55 | 0 | 5 | 2 | 8 | 7 | 0.59 | 0 | 3 | 2 | 11 | 6 | 0.73 | 0 | 4 | 2 | 9 | 6 | 0.66 | 0 | 4 | 2 | 9 | 6 | 0.66 |
0.1 | 0.6 | 0 | 4 | 1 | 5 | 5 | 0.66 | 0 | 3 | 1 | 6 | 4 | 0.73 | 0 | 5 | 2 | 7 | 6 | 0.59 | 0 | 3 | 2 | 8 | 5 | 0.73 |
0.15 | 0.35 | 2 | 17 | 7 | 32 | 25 | 0.52 | 3 | 19 | 7 | 33 | 24 | 0.68 |
0.15 | 0.4 | 2 | 15 | 5 | 21 | 18 | 0.60 | 1 | 10 | 5 | 22 | 16 | 0.54 | 2 | 16 | 7 | 27 | 21 | 0.56 | 2 | 13 | 7 | 29 | 18 | 0.69 |
0.15 | 0.45 | 1 | 9 | 4 | 16 | 12 | 0.60 | 1 | 8 | 4 | 17 | 12 | 0.66 | 1 | 9 | 5 | 19 | 14 | 0.60 | 1 | 9 | 5 | 19 | 14 | 0.60 |
0.15 | 0.5 | 0 | 5 | 3 | 12 | 9 | 0.44 | 1 | 7 | 3 | 13 | 9 | 0.72 | 1 | 8 | 5 | 17 | 12 | 0.66 | 1 | 7 | 5 | 18 | 11 | 0.72 |
0.15 | 0.55 | 1 | 6 | 3 | 11 | 8 | 0.78 | 1 | 6 | 3 | 11 | 8 | 0.78 | 0 | 4 | 4 | 13 | 9 | 0.52 | 1 | 6 | 4 | 14 | 8 | 0.78 |
0.15 | 0.6 | 0 | 5 | 2 | 7 | 7 | 0.44 | 0 | 3 | 2 | 8 | 5 | 0.61 | 1 | 7 | 3 | 9 | 8 | 0.72 | 1 | 5 | 3 | 11 | 6 | 0.84 |
0.15 | 0.65 | 0 | 3 | 2 | 7 | 5 | 0.61 | 0 | 3 | 2 | 7 | 5 | 0.61 | 0 | 3 | 3 | 9 | 6 | 0.61 | 0 | 3 | 3 | 9 | 6 | 0.61 |
0.15 | 0.7 | 0 | 3 | 2 | 6 | 5 | 0.61 | 0 | 2 | 2 | 8 | 4 | 0.72 | 0 | 3 | 2 | 6 | 5 | 0.61 | 0 | 3 | 2 | 6 | 5 | 0.61 |
0.2 | 0.45 | 3 | 15 | 7 | 24 | 19 | 0.65 | 3 | 14 | 7 | 25 | 18 | 0.70 |
---|
0.2 | 0.5 | 2 | 10 | 5 | 17 | 13 | 0.68 | 2 | 10 | 5 | 17 | 13 | 0.68 | 2 | 12 | 7 | 21 | 16 | 0.56 | 2 | 10 | 7 | 22 | 14 | 0.68 |
0.2 | 0.55 | 0 | 4 | 4 | 13 | 10 | 0.41 | 0 | 4 | 4 | 13 | 10 | 0.41 | 1 | 7 | 6 | 17 | 12 | 0.58 | 2 | 8 | 7 | 22 | 11 | 0.80 |
0.2 | 0.6 | 1 | 7 | 3 | 9 | 8 | 0.58 | 1 | 5 | 4 | 14 | 8 | 0.74 | 1 | 8 | 5 | 13 | 11 | 0.50 | 1 | 5 | 6 | 18 | 9 | 0.74 |
0.2 | 0.65 | 0 | 3 | 3 | 9 | 6 | 0.51 | 0 | 3 | 3 | 9 | 6 | 0.51 | 1 | 6 | 4 | 10 | 8 | 0.66 | 1 | 5 | 4 | 11 | 7 | 0.74 |
0.2 | 0.7 | 0 | 3 | 2 | 6 | 5 | 0.51 | 0 | 3 | 2 | 6 | 5 | 0.51 | 2 | 6 | 3 | 8 | 7 | 0.90 | 1 | 4 | 4 | 11 | 6 | 0.82 |
0.25 | 0.55 | 5 | 15 | 6 | 17 | 16 | 0.85 | 2 | 9 | 7 | 20 | 14 | 0.60 |
0.25 | 0.6 | 1 | 8 | 5 | 13 | 12 | 0.37 | 2 | 8 | 5 | 14 | 10 | 0.68 | 2 | 9 | 7 | 17 | 13 | 0.60 | 2 | 8 | 7 | 18 | 12 | 0.68 |
0.25 | 0.65 | 1 | 6 | 4 | 10 | 8 | 0.53 | 1 | 5 | 4 | 11 | 8 | 0.63 | 1 | 6 | 6 | 14 | 10 | 0.53 | 1 | 5 | 6 | 15 | 9 | 0.63 |
0.25 | 0.7 | 2 | 6 | 3 | 8 | 7 | 0.83 | 1 | 4 | 4 | 11 | 6 | 0.74 | 1 | 5 | 5 | 11 | 8 | 0.63 | 1 | 4 | 6 | 15 | 7 | 0.74 |
0.25 | 0.75 | 1 | 4 | 3 | 7 | 5 | 0.74 | 0 | 2 | 3 | 8 | 5 | 0.56 | 0 | 2 | 4 | 9 | 6 | 0.56 | 0 | 2 | 4 | 9 | 6 | 0.56 |
0.25 | 0.8 | 0 | 2 | 2 | 5 | 4 | 0.56 | 0 | 2 | 2 | 5 | 4 | 0.56 | 0 | 2 | 4 | 8 | 5 | 0.56 | 0 | 2 | 4 | 8 | 5 | 0.56 |
0.3 | 0.6 | 2 | 9 | 8 | 19 | 15 | 0.46 | 2 | 8 | 8 | 20 | 14 | 0.55 |
0.3 | 0.65 | 3 | 9 | 6 | 14 | 11 | 0.73 | 2 | 7 | 7 | 16 | 11 | 0.65 |
0.3 | 0.7 | 1 | 5 | 5 | 11 | 8 | 0.53 | 2 | 6 | 5 | 12 | 8 | 0.74 | 3 | 9 | 7 | 14 | 11 | 0.73 | 2 | 6 | 7 | 15 | 9 | 0.74 |
0.3 | 0.75 | 0 | 2 | 4 | 9 | 6 | 0.49 | 0 | 2 | 4 | 9 | 6 | 0.49 | 2 | 6 | 5 | 10 | 8 | 0.74 | 1 | 4 | 6 | 12 | 7 | 0.65 |
0.3 | 0.8 | 1 | 4 | 3 | 6 | 5 | 0.65 | 1 | 4 | 3 | 6 | 5 | 0.65 | 2 | 5 | 4 | 8 | 6 | 0.84 | 2 | 5 | 4 | 8 | 6 | 0.84 |
0.35 | 0.7 | 3 | 9 | 7 | 14 | 11 | 0.61 | 2 | 6 | 7 | 15 | 10 | 0.65 |
0.35 | 0.75 | 2 | 6 | 5 | 10 | 8 | 0.65 | 2 | 6 | 5 | 10 | 8 | 0.65 | 2 | 6 | 7 | 13 | 9 | 0.65 | 2 | 6 | 7 | 13 | 9 | 0.65 |
0.35 | 0.8 | 0 | 2 | 4 | 8 | 6 | 0.42 | 0 | 2 | 4 | 8 | 6 | 0.42 | 2 | 5 | 6 | 11 | 7 | 0.76 | 2 | 5 | 6 | 11 | 7 | 0.76 |
0.35 | 0.85 | 1 | 3 | 3 | 6 | 4 | 0.72 | 1 | 3 | 3 | 6 | 4 | 0.72 | 1 | 3 | 5 | 9 | 5 | 0.72 | 1 | 3 | 5 | 9 | 5 | 0.72 |
0.35 | 0.9 | 1 | 3 | 3 | 5 | 4 | 0.72 | 1 | 3 | 3 | 5 | 4 | 0.72 | 1 | 3 | 4 | 7 | 5 | 0.72 | 1 | 3 | 4 | 7 | 5 | 0.72 |
0.4 | 0.75 | 2 | 6 | 7 | 13 | 10 | 0.54 | 2 | 6 | 7 | 13 | 10 | 0.54 |
0.4 | 0.8 | 1 | 4 | 5 | 9 | 7 | 0.48 | 1 | 4 | 5 | 9 | 7 | 0.48 | 3 | 8 | 8 | 13 | 11 | 0.59 | 2 | 5 | 8 | 14 | 8 | 0.68 |
0.4 | 0.85 | 0 | 2 | 4 | 7 | 6 | 0.36 | 1 | 3 | 5 | 9 | 6 | 0.65 | 1 | 3 | 6 | 10 | 6 | 0.65 | 1 | 3 | 6 | 10 | 6 | 0.65 |
0.4 | 0.9 | 1 | 3 | 3 | 5 | 4 | 0.65 | 1 | 3 | 3 | 5 | 4 | 0.65 | 2 | 4 | 5 | 8 | 5 | 0.82 | 2 | 4 | 5 | 8 | 5 | 0.82 |
0.4 | 0.95 | 0 | 1 | 3 | 5 | 3 | 0.60 | 0 | 1 | 3 | 5 | 3 | 0.60 | 0 | 1 | 4 | 6 | 3 | 0.60 | 1 | 2 | 5 | 8 | 3 | 0.84 |
0.45 | 0.8 | 4 | 9 | 8 | 13 | 11 | 0.62 | 2 | 5 | 9 | 15 | 10 | 0.59 |
0.45 | 0.85 | 1 | 3 | 6 | 10 | 6 | 0.57 | 1 | 3 | 6 | 10 | 6 | 0.57 | 1 | 4 | 8 | 12 | 9 | 0.39 | 1 | 3 | 9 | 14 | 8 | 0.57 |
0.45 | 0.9 | 3 | 5 | 4 | 7 | 6 | 0.87 | 2 | 4 | 5 | 8 | 5 | 0.76 | 2 | 4 | 6 | 9 | 6 | 0.76 | 2 | 4 | 6 | 9 | 6 | 0.76 |
0.45 | 0.95 | 0 | 1 | 4 | 6 | 4 | 0.55 | 1 | 2 | 4 | 7 | 4 | 0.80 | 0 | 1 | 5 | 7 | 4 | 0.55 | 0 | 1 | 5 | 7 | 4 | 0.55 |
0.5 | 0.85 | 4 | 8 | 8 | 12 | 10 | 0.64 | 4 | 7 | 8 | 13 | 9 | 0.77 |
0.5 | 0.9 | 2 | 4 | 6 | 9 | 6 | 0.69 | 2 | 4 | 6 | 9 | 6 | 0.69 | 3 | 6 | 8 | 11 | 8 | 0.66 | 3 | 5 | 9 | 13 | 7 | 0.81 |
0.5 | 0.95 | 0 | 1 | 4 | 6 | 4 | 0.50 | 1 | 2 | 5 | 8 | 4 | 0.75 | 0 | 1 | 6 | 8 | 5 | 0.50 | 1 | 2 | 8 | 12 | 5 | 0.75 |
Abbreviations
- p0 = proportion of success at or below which treatment is abandoned
- p1 = proportion of success at or above which treatment will be accepted for
further development and trials
- n1 = maximum sample size required in stage 1
- r1 = number of successes above which stage 2 can be entered, and at or below
which when n1 cases is reached the trial ends and the treatment abandoned.
- nTot = the total maximum sample size (stage 1 and 2 combined)
- rTot = the total number of successes (stage 1 and 2 combined) above which
the study can be terminated and the treatment accepted for further development and trials, and at or
below which when nTot cases is reached the treatment is abandoned.
- EN = expected sample size, an estimated average sample size that will be used
before the trial terminates. This is a measure of efficiency in detecting
useful treatments
- PET = probability of early termination (when treatment is abandoned), a measure
of efficiency in rejecting ineffective treatments.
- The table was calculated using α (probability of Type I Error) of 0.05 and power (1-β) of 0.8,
β being probability of Type II Error.
Models
- Minimax : the model to be used when the treatment is expected
to be useful and accepted for Phase III trial, as it has smaller sample size
in stage 1 and a lower EN, so more quickly to enter stage 2 and terminate
with acceptance of treatment.
- Optimal : the model that should be used when the treatment is
expected to be rejected, as it has a higher PET, so more likely to be rejected
earlier if the success rate is less than expected.
Simon R (1989) Optimal two-stage designs for phase II clinical trials.
Control Clin Trials 10:1-10
Machin D, Campbell M, Fayers, P, Pinol A (1997) Sample Size Tables for
Clinical Studies. Second Ed. Blackwell Science IBSN 0-86542-870-0 p. 256-257
|